Claims for Patent: 10,314,904

Summary for Patent: 10,314,904

Title:	Methods for enhancing efficacy of a vaccine by administering an IL-4R antagonist
Abstract:	The present invention provides methods for enhancing the efficacy and/or safety of a vaccine. In certain embodiments, the invention provides methods to increase or potentiate the immune response to a vaccine in a subject in need thereof. The methods of the present invention comprise administering to a subject in need thereof an interleukin-4 receptor (IL-4R) antagonist such as an anti-IL-4R antibody in combination with said vaccine. In certain embodiments, the methods of the present invention are used to afford enhanced protection to an infectious disease such as whooping cough.
Inventor(s):	Purcell; Lisa (Garnerville, NY), Graham; Neil (Croton-on-Hudson, NY), Murphy; Andrew J. (Croton-on-Hudson, NY), Evans; Robert (Cambridge, MA)
Assignee:	Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
Application Number:	15/436,032
Patent Claims:	1. A method for enhancing the efficacy or safety, or both of a vaccine comprising: (a) selecting a subject that is susceptible to a pertussis infection; and (b) administering a vaccine specific to the pertussis infection in combination with an IL-4R antagonist to the subject, wherein the IL-4R antagonist is an antibody or antigen-binding fragment thereof that binds IL-4R.alpha., and comprises three HCDRs (HCDR1, HCDR2 and HCDR3) and three LCDRs (LCDR1, LCDR2 and LCDR3), wherein the HCDR1 comprises the amino acid sequence of SEQ ID NO: 3; the HCDR2 comprises the amino acid sequence of SEQ ID NO: 4; the HCDR3 comprises the amino acid sequence of SEQ ID NO: 5; the LCDR1 comprises the amino acid sequence of SEQ ID NO: 6; the LCDR2 comprises the amino acid sequence of SEQ ID NO: 7; and the LCDR3 comprises the amino acid sequence of SEQ ID NO: 8. 2. The method of claim 1, wherein the IL-4R antagonist is administered before, after or concurrent with the vaccine. 3. The method of claim 2, wherein the vaccine is administered at an initial dose followed by one or more subsequent (booster) doses. 4. The method of claim 3, wherein one or more doses of the IL-4R antagonist are administered before each dose of the vaccine. 5. The method of claim 4 comprising administering a dose of the IL-4R antagonist concurrent with each dose of the vaccine. 6. The method of claim 2 comprising administration of one or more doses of the IL-4R antagonist before the vaccine followed by a dose of the IL-4R antagonist concurrent with the vaccine, optionally followed by one or more doses of the IL-4R antagonist. 7. The method of claim 6, wherein each dose of the IL-4R antagonist comprises 1-10 mg/kg of the subject's weight. 8. The method of claim 6, wherein each dose comprises 10-600 mg of the IL-4R antagonist. 9. The method of claim 1, wherein the pertussis vaccine is selected from the group consisting of whole-cell vaccine or acellular vaccine. 10. The method of claim 9, wherein the vaccine is acellular pertussis (aP) vaccine. 11. The method of claim 1, wherein the subject is allergic to the vaccine. 12. The method of claim 1, wherein enhancing the efficacy or safety, or both of a vaccine comprises at least one of the effects selected from the group consisting of prevention of infection and transmission of infectious disease, increase in the duration of resistance to pathogen infection, faster pathogen clearance from infected host, reduction in pathogen load in infected organ, increase in T helper 1 (Th1) type antigen-specific IgG isotype antibodies, reduction or abrogation of IgE elicited by the vaccine, reduction in T helper 2 (Th2) response elicited by the vaccine, reduction in Th2-type antigen-specific IgG isotype antibodies, and reduction in allergic response to the vaccine. 13. The method of claim 1, wherein the antibody or antigen-binding fragment thereof prevents the interaction of IL-4 or IL-13, or both with a type 1 or type 2 IL-4 receptor. 14. The method of claim 13, wherein the antibody or antigen-binding fragment thereof prevents the interaction of IL-4 with both type 1 and type 2 IL-4 receptors. 15. The method of claim 1, wherein the antibody or antigen-binding fragment comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 1 and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 2. 16. The method of claim 1, wherein the IL-4R antagonist is dupilumab or a bioequivalent thereof. 17. The method of claim 7, wherein each dose of the IL-4R antagonist comprises 1 mg/kg, 2 mg/kg, 3 mg/kg, 5 mg/kg or 6 mg/kg of the subject's weight. 18. The method of claim 8, wherein each dose comprises 200 mg or 300 mg of the IL-4R antagonist. 19. The method of claim 8, wherein each dose comprises 100 mg of the IL-4R antagonist. 20. The method of claim 6, wherein the IL-4R antagonist is administered once a week, once every 2 weeks, once every 3 weeks, or once every 4 weeks. 21. The method of claim 1, wherein the IL-4R antagonist is administered subcutaneously.

Details for Patent 10,314,904

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	03/28/2017		2036-02-19
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	10/19/2018		2036-02-19
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	06/18/2020		2036-02-19
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	06/14/2021		2036-02-19
Regeneron Pharmaceuticals, Inc.	DUPIXENT	dupilumab	Injection	761055	10/20/2021		2036-02-19